Final AE Regulatory Guidance: Reporting/Communication of Safety Information from Clinical Trials to IRBs

Upcoming Courses
Course #: BI14179
January 25, 2021
12:00 PM - 1:30 PM Eastern

Course Description

This web seminar presents content and impact discussion of the FDA and Office of Human Research Protections (OHRP) Adverse Event reporting guidance documents. The guidance documents address issues of Adverse Event information exchange between stakeholders and propose solutions to the issues of the quality of information being sent to the IRBs. The guidance impacts the activities of the research site, IRB, and sponsor/CRO’s role in compiling and/or communicating Adverse Event information during a research study, changing the industry’s current practices.

Learning Objectives

  • Appreciate the changing regulatory climate and the impact on safety reporting in clinical trials
  • Explain the global response and recommendations for more meaningful safety reporting between stakeholders
  • Describe the FDA’s response: January 2009 Final Guidance
  • Describe the OHRP’s response: January 2007 Final Guidance
  • Recognize implications for current practices
  • Examine case scenarios

Who Should Attend

  • Sites: Principal Investigators, Clinical Research Coordinators, Managers
  • Sponsors: Clinical Research Associates, Sponsor Clinical Operations, Safety Information Specialists, Regulatory Professionals


Elizabeth Ronk Nelson, M.P.H.

Click here for complete trainer biographies

Registration Fees


Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-19-040-L01-P. Released: 10/19. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.